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ISO 13485 · FDA QMSR · MDSAP · GMP

Medical Device QMS Consultants: ISO 13485, MDSAP, QMSR & GMP

We design, implement and maintain quality management systems for medical device and IVD manufacturers, built on ISO 13485 and extended for EU MDR and IVDR, the FDA QMSR, MDSAP and other markets, so one system gets you through every audit and inspection.

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1QMS for every market
Feb 2026FDA QMSR in force
5MDSAP regulators, one audit
The basics

Why your QMS matters

A quality management system is the backbone of regulatory compliance. It controls how you design, buy, make, release and monitor your devices, and it is what Notified Bodies, the FDA and other regulators audit first.

Most manufacturers build on ISO 13485:2016, then add what each market requires. Done well, it reduces nonconformities, speeds up certification and supports CE marking, FDA clearance and global registrations at the same time.

Built on ISO 13485The common base for EU, US, MDSAP and UK requirements.
Sized for your businessProcedures that fit your team and products, not a template pile.
Audit-readyPrepared for Notified Body audits, FDA inspections and MDSAP.
By market

QMS requirements by market

One ISO 13485 system can meet all of these, with market-specific additions.

MarketQMS requirementWho audits
European UnionEU MDR / IVDR Article 10, using EN ISO 13485Notified Body
United States21 CFR 820 Quality Management System Regulation (QMSR), incorporating ISO 13485FDA inspection, or MDSAP audit
CanadaMDSAP certificate for Class II to IV device licencesMDSAP auditing organisation
Australia, Brazil, JapanMDSAP audit reports accepted by the regulatorsMDSAP auditing organisation
United KingdomUK MDR 2002, using ISO 13485UK Approved Body
IndiaMedical Devices Rules 2017, Fifth Schedule QMSCDSCO or State Licensing Authority, with notified bodies for Class A and B
How it works

How we build your QMS, step by step

From first gap assessment to a certified system that stays compliant.

  1. 1

    Gap assessment

    Week 1–2

    We review your current processes and records against ISO 13485 and your target markets.

  2. 2

    QMS design

    Scope & structure

    We define scope, processes, quality policy and objectives, and the document structure.

  3. 3

    Procedures & records

    Documentation

    We write the quality manual, procedures, work instructions and forms your team will actually use.

  4. 4

    Implementation & training

    Roll-out

    We train your team and help run the processes so records build up before the audit.

  5. 5

    Internal audit & management review

    Readiness

    We run a full internal audit and management review and close the findings.

  6. 6

    Certification or inspection support

    Audit day

    We support the Notified Body, MDSAP or FDA audit and help answer findings.

  7. 7

    Maintain & improve

    Ongoing

    We support CAPA, surveillance audits, regulation changes and continual improvement.

Core processes

The QMS processes auditors look at first

01
Document & record controlApproved, current documents and retrievable records.
02
Design & developmentDesign inputs, outputs, verification, validation and transfer.
03
Risk managementISO 14971 applied across the product lifecycle.
04
Supplier controlEvaluation, approval and monitoring of critical suppliers.
05
Production & process controlValidated processes, traceability and device history records.
06
Complaints & vigilanceHandling, investigation and reporting to regulators.
07
CAPARoot cause, correction and effectiveness checks.
08
Internal audit & management reviewEvidence the system works and improves.
Our services

Our quality system services

ISO 13485 implementationQMS design, documentation and certification support.
MDSAP readinessOne audit for the USA, Canada, Australia, Brazil and Japan.
FDA QMSR transitionMoving from the old QSR to the new 21 CFR 820.
GMP for manufacturing sitesFacility layout, process validation and shop-floor controls.
Internal auditsIndependent audits against ISO 13485, QMSR and MDSAP.
Audit finding responsesCAPA plans for Notified Body, MDSAP and FDA 483 findings.

Quality system services in detail

ISO 13485 Certification Process MDSAP Certification Process 21 CFR 820 & QMSR GMP Consultants US FDA Consultants ISO 14971 Risk Management
FAQ

Medical device QMS FAQs

What is a quality management system for medical devices?

A QMS is the set of documented processes a manufacturer uses to design, produce, release and monitor safe, effective devices. For medical devices and IVDs it is usually built on ISO 13485:2016 and adapted to each market's regulations.

Is ISO 13485 mandatory?

Not by name in every market, but in practice yes. EU MDR and IVDR require a QMS, and EN ISO 13485 is the harmonised standard used to show it. The FDA's QMSR incorporates ISO 13485 by reference, and MDSAP audits against it.

What is the FDA QMSR and when did it take effect?

The Quality Management System Regulation replaced the old 21 CFR 820 Quality System Regulation on 2 February 2026. It incorporates ISO 13485:2016 by reference, with some additional FDA requirements.

Can one QMS cover the EU, USA and other markets?

Yes. A QMS built on ISO 13485 can be extended with market-specific requirements for EU MDR/IVDR, FDA QMSR, MDSAP countries, UKCA and India's CDSCO, so you run one system rather than several.

Does an MDSAP audit replace FDA inspections?

The FDA accepts MDSAP audit reports in place of routine FDA inspections. It does not replace for-cause inspections or pre-approval inspections for PMA devices.

How long does it take to implement a QMS?

For a small to mid-sized manufacturer starting from scratch, implementation to certification readiness often takes 4 to 6 months, depending on product complexity and how many processes already exist.

Is your QMS ready for its next audit?

Send us your details using the form below and we'll run a free QMS gap assessment.

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